Health

File: This undated file photo provided by the U.S. Food and Drug Administration shows the tip of an endoscopic retrograde cholangiopancreatography (ERCP) duodenoscope, attached to a long tube, not shown. Cedars-Sinai Medical Center said on Wednesday, March 4, 2015, that four patients had been infected with a superbug linked to a contaminated medical scope — the second Los Angeles hospital to report infections from a superbug known as CRE.
U.S. Food and Drug Administration/AP

Chris Keller|June 22, 2016

The Pasadena Public Health Department has recommended Huntington Memorial Hospital expand the number of patients it's notifying that they may have been infected during a procedure to examine pancreatic and bile ducts with medical scopes found to have spread infections at hospitals around the country.

Sixteen Huntington Memorial Hospital patients were infected with drug-resistant bacteria between January 2013 and August 2015 following a procedure known as Endoscopic Retrograde Cholangio-Pancreatography, according to a report of the outbreak released earlier this month. Eleven of the patients died. Three of the medical scopes - two manufactured by Olympus - tested positive for the bacteria.

Huntington told health officials late last month that it had already notified 88 patients who got the procedure between January 2015 and August 2015. But in a report on May 20, the health department told the hospital it should notify patients even further back, to January 2013.

"In the interests of full disclosure, the Pasadena Health Dept. felt it prudent to let all patients know," Pasadena Public Information Officer William Boyer said in an email.

Huntington Memorial Hospital Director of Public Relations Derek Clark said in an email that notifications to the expanded group of patients are "ongoing" and the hospital is offering free screenings for patients who might have been exposed.

Clark declined to say how many patients may be affected or how they are being notified. However, the health department report states the hospital performs about 300 of the procedures per year.

The Pasadena Public Health Department report outlines additional recommendations to the hospital. These include following standards for cleaning, disinfecting, and servicing duodenoscopes and creating a unit to monitor, investigate, control and prevent infections related to the use of these scopes.

In addition, health officials asked the hospital to inform future patients about the risk. Huntington officials have until late August to report back on whether they followed the recommendations.

Health officials across the country have focused much of their attention on the design of the gastrointestinal scope. Deadly germs can become trapped inside the scope, which is difficult to clean, and get passed to the next patient.

The Food and Drug Administration in August issued a warning letter to Olympus after it failed to alert regulators to a cluster of 16 infections in patients who underwent procedures with the company's scopes in 2012. The company did not report the problems to the FDA until 2015, when the company was already under scrutiny for a more recent series of outbreaks.

After it responded to the outbreak, Pasadena Public Health Department recommended the hospital notify patients who had the procedure between January 2015 and August 2015 that they might be at risk. Of the 88 patients contacted by mail and phone, according to the report, 15 chose to be screened for infection; none tested positive.

No additional infections were found during a monitoring period between Aug. 20, 2015 and Dec. 11, 2015, the report stated.

But in March of this year, Huntington staff identified an additional positive test result for a patient who had undergone the procedure in July 2013. The patient had undergone a previous screening which had come back negative, the report said.

As a result, health officials prompted the hospital to extend notifications to patients back to 2013.

"This broad bacterial contamination supports the hypothesis that duodenoscope disinfection and/or AER cleaning and maintenance were insufficient to prevent the spread of infection," the report said. Along with the complex design of the scope, it also blamed the hospital's use of storage and disinfection procedures that are not consistent with manufacturer's guidelines.

Olympus and the other manufacturers have come under fire from critics who say the ways the scopes are designed make them exceedingly difficult to thoroughly clean.

Clark, in his emailed statement, said the hospital takes responsibility for the deficiencies outlined in the report, and said "these scopes are an issue facing many hospitals."

In May, the FDA backed off a recall of some 2,800 scope-cleaning machines in use at hospitals and clinics nationwide despite a finding by a top agency scientist last year that the action was "necessary to protect public health."